Centralized sterile drug products distribution and automated management of sterile compounding stations

ABSTRACT

Central management of dose order preparation retrieves an unprocessed dose order record, selects a workstation from a set of workstations, forwards the order for conversion into a drug dosage form, and repeats the process for additional unprocessed dose order records. Depending on the operation type of the selected workstation (manual, automatic), protocol information concerning preparation of the dose order is selectively provided to the selected workstation. Interrogatable elements enable tracking of dose orders and dosage forms throughout preparation, storage and distribution cycles. Further methods enable rapid fulfillment by utilizing inventory ahead of drug order processing if suitable dosage forms exist in inventory records.

FIELD OF THE INVENTION

The present invention relates to the management of medication doseorders and the environment within which the preparation of sterile dosesoccurs, and more particularly to some or all of the systems and stepstaken in connection with the receipt, processing, filling, management,and distribution of medication dose orders and in connection with themanagement of medication preparation workstations.

BACKGROUND OF THE INVENTION

In many medical facilities medication orders are transmitted to apharmacy from various locations throughout the hospital and by variousmeans of communication. The process by which these medication orders aremanaged involves many discrete steps. Orders must be entered,transmitted and received by the pharmacy, validated, and filledaccording to manufacturer's specifications or established institutionalguidelines. The filling process involves the selection and, whererequired, preparation of drug products for administration to patients incompliance with the validated order. Once filled, the resulting drugproducts (i.e., doses) must be delivered to the patient that requiresthem. One environment, by way of example, in which such transmissionsand processes occur, is a hospital.

There are points in the process that are susceptible to miscommunicationor loss of information. This can be problematic in terms of logging andauditing the processing and preparation of medications, which is oftenmandated by insurance and regulatory requirements. Additionally, thereare inefficiencies associated with the present process and management ofmedication orders from the point of origination or to the point ofconsumption.

Physicians and other care providers order medications for hospitalizedpatients by generating medication orders in their patient record. When apharmacy receives such an order, a pharmacist performs a variety ofoperational and clinical functions to ensure that the order is safe andappropriate and issues a medication dose order for the release ofmedications for administration to the patient. Current pharmacy practicelimits the amount of that medication to that which is immediately neededboth for reasons of patient safety and economics. Pharmacy computersystems regularly review the currently active medication orders, andgenerate additional medication dose orders as needed to maintain thepatient supply. However, pharmacy computer systems do not providepreparation instructions to the sterile products compounding technician.

The pharmacy operationally receives these medication dose orders in theform of printed labels, typically generated by a hospital pharmacycomputer system, one for each medication dose order to be dispensed. Inmany cases, a separate label is printed for each dose to be dispensed.Pharmacists and technicians use these labels as work documents toidentify the medications to make and properly prepare and issue thedesired medication. The labels are then used as address labels to ensurethat the medications are routed to the correct patient for use. Theselabels lack detailed preparation steps, causing the technician to relyon his or her memory of the preparation procedures and guidelines, seekinput from a co-worker, or find a manufacturer's package insert or awritten institutional guideline.

One hazard of this method is that the label represents the only recordof the work needing to be performed with the result that, if the labelis lost or damaged, the work may not be performed (that is, themedication dose order may not be fulfilled) and the omission does notbecome known until a caregiver complains because they cannot locate themedication, or because a patient experiences an adverse event because ofomitted medication.

U.S. Pat. No. 7,096,212 for “Serial Data Capture and Processing” andU.S. Patent Application No. 2003/0097368 for “Data Transmission Capturein Support of Medication Preparation” describe technology for automatingthe preparation of medication dose orders in response to the printing ofsuch labels, the entire disclosure of which is hereby incorporated byreference, as though set forth in its entirety. However, these systemsdo not manage the distribution of medication dose orders to the variouspharmacy workstations at which they are to be prepared, nor do theytrack the distribution of the completed dose orders to the patient forwhom they are intended.

While many medications can be prepared by automated systems containing“built in” knowledge of correct preparation procedures, there are stilllarge numbers of medication dose orders that require manual preparation,or institutions whose size precludes the incorporation of automationtechnology. The information and knowledge regarding how to prepare themedication is typically transferred verbally from one person to another.Thus, if a clinician receives an order for which he is unaware of thecorrect procedure for fulfillment, the clinician would have to requestassistance, and thereby acknowledge a lack of training for thatparticular task. However, seeking training can be a source ofembarrassment or be perceived as an undesired delay, either scenarioproviding a potential basis for the clinician to potentially use animproper procedure for the preparation of a particular medication,significantly increasing the possibility of a serious medication errordue to flawed preparation procedures. Repeated conduct in this regardcan result in “self trained” experience in a manner which isinconsistent with published procedures for handling that medication.Typically, the correct procedures are defined and written in a manual orother documentation. However, there is currently no efficient way topresent the relevant excerpt of the manual to the clinician in relationto the particular medication order to be processed.

Furthermore, after a doctor or nurse enters a medication order,determining the status of the order requires manual intervention. Theprogress of the order can not easily be determined. The order must belocated, determined if it has been filled, then possibly locatedsomewhere throughout a facility such as a hospital, which can becomplicated further as the medication dose is being transferred to thepatient or as patients are moved from one location to another (e.g.,from the patient's room to physical therapy or a lab).

Workload management systems for hospitals and sterile productspreparation are unsophisticated and incapable of properly managing theprocess, causing conflicts between the level of staffing provided andthe level of work to be performed.

Finally, delivery of medication dose orders to patient care areas in ahospital is not well-controlled, sometimes resulting in care-givers inpatient care areas in a hospital being unaware that medication theyrequire for care of a given patient has been delivered to the medicationstorage area where they are rendering care. This can result in lostproductivity in the pharmacy and in the patient care areas while thepharmacist and the care giver attempt to sort out whether or not amedication dose order of interest has been completed.

The present invention addresses one or more of these and other problemsto provide a medication order management, fulfillment, and trackingsystem. As more and more automated dispensing devices are developed,there is additional value in a mechanism in accordance with the presentinvention for automatically routing medication dose orders generated bythe hospital pharmacy computer system to the most appropriate automatedor manual workstations in the pharmacy and then tracking them to ensurethat they are completed and distributed to their intended recipients. Aswork is completed at and returned from these workstations, it isvaluable to know that the medication dose orders are ready fordistribution and to prompt pharmacy personnel to get them delivered tothe patient care areas.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a method for centrallymanaging dose order preparation comprises the steps of retrieving a doseorder record having an unprocessed status, selecting a workstation andforwarding the order for conversion into a drug dosage form, andrepeating the steps for additional dose order records.

In accordance with a further aspect of the present invention, theoperation type of the selected workstation is determined, and a protocolconcerning preparation of the unprocessed dose order is selectivelyprovided to the selected workstation based on the operation type of theselected workstation.

In further aspects in accordance with the foregoing method, the dosageform can support an interrogatable tag which can be scanned in order tolink the dosage form, and optionally also its current location, to thedose order record. Also, the foregoing method can include the additionalstep of arranging a plurality of dose order records in accordance with arule such as urgency, type (solid, oral, intravenous), or medication.

In accordance with another aspect of the invention, a method forcentrally managing logistics of a dose order fulfillment comprises thesteps of receiving a dose order having a first priority for completion,comparing the dose order against an inventory record of prepared drugdoses for a match, and, in the event of the match, directing a person toa location associated with the matched, prepared drug dose, registeringthe retrieval of the prepared drug dose from the location for deliveryto another location, updating the inventory record, and instructing thepreparation of the dose order at a second station for completion at apriority which is not greater than the first priority.

A database of interactive Standard Operating Procedures can be utilizedfor each drug that might be anticipated as needing preparation. Suchdatabase can perform dose calculations and manipulations of final volumeand dose of the drug in accordance with unique aspects of the specificdose being prepared.

In accordance with yet a further aspect of this invention, confirmationscan be performed to ensure that a proper preparation procedure wasfollowed.

The invention can further log the steps of preparation and confirmationto provide a way to review or audit a prepared dose to ensure that thepreparation was performed properly and that the expected values wereachieved. Additionally, the current status of a medication dose ordercan be queried and retrieved at any time from an associated workstation.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The foregoing and other features of the present invention will be morereadily apparent from the following detailed description and drawings ofthe illustrative embodiments of the invention wherein like referencenumbers refer to similar elements throughout the views and in which:

FIGS. 1 and 1A illustrate a process for receiving, processing, andpreparing medication dose orders in accordance with one embodiment ofthe present invention; and

FIG. 2 illustrates a process for managing and distributing preparedmedication doses in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The present invention relates to the capture, processing, tracking, anddistribution of medications. More particularly, the invention relates toan automated fulfillment system and method for receiving incomingmedication dose orders, processing those orders, preferably in anefficient and optimized manner through the selective use of either anautomated medication preparation fulfillment system or a manualmedication preparation, and tracking the prepared medication dosethrough to its predetermined destination.

By way of overview and example, a doctor can enter one or moremedication orders (“medication order”) at a terminal in a hospital. Theterminal can be connected via a network or to a computer system in thepharmacy. When the order is processed by the pharmacy computer systemand labels for medication doses are generated, the data contained in theorder and on the labels is captured, processed, and parsed by a computerimplemented system to create individual medication dose orders (“doseorder”) and associated database records. The software managing themedication dose order processing distributes the orders to variouscompounding workstations (e.g., automated sterile compounding stationsor manual processing stations) preferably in an optimized manner, asdescribed below. At each stage of the order processing, the databaserecord associated with the dose order is updated to reflect its statusand location. Once the medication order is fulfilled, the resulting doseorder is labeled preferably so as to associate it with a patient carelocation, represented in the pharmacy as a delivery container, such as abin.

The association in the data record can be a result of linking theinterrogation of a scanable element to the dose order record. A codesupported by or secured to the dose itself and a code associated withthe bin at the dosage form's current location can both be interrogatedand then that information uploaded to a database. For example, the codescan be bar codes and can be sensed using a bar code scanner. Theparticular “scanner” used and the manner of “scanning” can be variedwithin the context of the invention to suit the requirements of a givenimplementation. Thus, for example, the code can be an opticallyscannable bar code or an interrogatable code such as an RFID tag that issupported in lieu of or in addition to bar codes, plain text, or othercodes. The terms “scanner” and “scanning” are intended to includewireless interrogation or passive data reception whether they are basedon an optical read, a radio frequency interrogation or an interrogationin some other frequency band, or a form of passive wireless datareception. More generally, the codes in scanable form are referred to as“tags.”

As the dose is transported through the hospital to its final location,the bin is scanned and any new location is scanned at various points totrack its progress through the hospital. If the dose is removed from thebin and placed into another bin, the new bin and the dose are scannedand associated in the database to correctly track the dose as it travelsin the new bin. Once the dose reaches the point of consumption (e.g.,the patient), the dose is removed from the bin and scanned so that itsstatus can be updated as “delivered.” Anyone with access to the systemcan track the progress of an order and determine its current location byinputting an identifier of the order. Furthermore, the fulfillmentsystem provides complete oversight of the process from end to end forauditing and compliance purposes.

With reference now to FIG. 1, a process is illustrated by which ordersare received, processed, and distributed within the pharmacy ormedication preparation center. At step 100, medication order streams arereceived by the pharmacy. Order streams can be received through variousmethods. For example, a medication order can be entered into a computerterminal in communication with the pharmacy over a network.Alternatively, the medication data can be captured by a monitor device,such as a serial data monitor, a network monitor, or a softwareapplication monitor. Typically these order streams represent dataintended to be printed on labels on a printer.

Medication order streams can contain a list of medication doses toprepare. Each dose order and dose is preferably associated withadditional related data such as the patient for whom the medication isintended, by when it should be delivered, and to where it should bedelivered. Further details can be associated with the medicationincluding the prescribing doctor, the time and date the prescription wasentered, the reason for medication, and other relevant informationfrequently recorded and associated with prescription.

Data streams containing medication dose data are preferably logged atstep 102 by a monitoring computer. Preferably, streams are logged in adatabase or other computer accessible medium. Logging data streamsenables extensive auditing and monitoring of the pharmacy—orhospital—dispensed medication. Because all data is logged, preferably inits raw form when it is first received by the pharmacy, no informationis lost, corrupted, or disassociated during the processing ordistribution of the medication. If necessary, an audit can be performedmanually, off-line, or by a separate software program to reconstruct thedata stream and all processing that should have or did occur after thepharmacy received the data stream. Furthermore, the logged data can beanalyzed with respect to dose order demand. The average volume, peakvolume, and standard deviation of dose orders can be determined forvarious historical time periods (e.g., day of the week, month, lastweek, last month, etc.). Based on this analysis, decisions regarding therequired staffing to fulfill the expected volume of dose orders can bemade.

Preferably, the data stream has an identifiable source. The source canbe explicitly identified within the stream of data, or it can bedeterminable by the fulfillment system. Source determination caninclude, for example, examining TCP/IP packet or its header/footerinformation, examining cryptographic signatures of the stream, or dataretrieved through additional network communication requesting thesource. The source is identified at step 104.

At step 106, the fulfillment system determines whether the data streamoriginated from one of a set of valid sources. This can includeidentifying the source of the data stream and testing that it is one ofthe sources among those in the set. Validating the source ensures eachmedication dose prepared by the fulfillment system is legitimate andoriginating from an authorized prescribing entity. Alternatively, thevalidation can ensure that the prescribing entity is presently entitledto have its prescriptions filled by the pharmacy. If the source is notvalid, the fulfillment system returns to step 100 to receive additionalstreams. Optionally, notifications can be sent to the source to informit that there were validation issues or that the window for continuedvalidation has one or more constraints (e.g., will expire in so-manydays due to an overdue invoice).

In one embodiment of the fulfillment system, the software executes in amulti-threaded or multi-process environment. Thus, multiple streams canbe processed simultaneously, by including necessary memory and databaselocks to ensure consistency. While the fulfillment system is describedabove as returning to step 100 to receive additional streams, persons ofskill in the art appreciate that streams can be received by a serverthread and dispatched for processing to other threads within athread-pool. Other multi-threaded or multi-process mechanisms can beused to control the processing of data streams received by thefulfillment system.

After determining that the source is valid, the stream is parsed toextract relevant information at step 110. The fulfillment system canparse various message and data formats. Moreover, the parser can beextensible, such that as new formats are implemented or included withinthe networked environment, a parser extension can be included in thefulfillment system to parse the new format. For example, if the datastream is a serial printer data stream, the fulfillment system candetermine the format of the data and pass the stream to the appropriateserial printer data parser. The printer data parser is configured toextract the dose medication contained within the stream. Preferably, theparser extracts all relevant data contained within the stream andmaintains a record of the extracted data. The parsing methodology ispreferably encapsulated in a library or set of modules that are calledupon, as necessary, to parse a stream of any determined format. Eachlibrary entry or module operates as a “parser,” as that term is usedherein.

The data stream can contain one or more dose orders. For example, thestream may contain a single prescription dose request by a doctor for asingle patient. Alternatively, the stream can include multiple doseorders for batch processing. The parser is preferably configured torecognize and discriminate between individual dose orders within astream. The discrimination of individual dose orders can be accomplishedby recognizing an order delimiter, or alternatively can be defined bythe format of the data stream.

The data extracted by the parser at step 110 is used to create a doseorder record at step 120. A dose order record is preferably created foreach individual dose order encoded by the data stream, and contains theinformation extracted from the stream. At step 122 each dose orderrecord can be stored in a database or other data storage system such asa suitable data-structure. Additionally, each dose order is preferablyassigned a unique dose identifier that can be used to track the doseorder and resulting dose through the fulfillment system.

The above description outlines the steps by which medication datastreams enter the pharmacy and are pre-processed in anticipation ofbeing filled by the pharmacy. Once the data streams have been processed,parsed into individual medication doses, and stored as dose recordswithin the fulfillment system, the pharmacy can prepare the medicationdoses identified by each dose record.

Referring now to FIG. 1A, order fulfillment processing commences at step130 at which the fulfillment system determines whether there are anyunfulfilled medication doses in the database. If no unfulfilled ordersexist, the fulfillment system can redirect its resources to processingincoming data streams at step 100, or completing or processing anyactive thread, as indicated schematically by the “end” terminator in theflow chart. However, if unfulfilled dose orders are in the database, thefulfillment system will retrieve an unfulfilled order at step 140. Atdecision 141, the system can determine whether a dose was previouslyprepared and stored which would satisfy the dose order. If no such doseexists, the dose order can be assigned to a medication preparationworkstation at step 142.

Dose order records stored in the database can be ordered or arranged inaccordance with one or more rules. For example, the rule can be tooptimize fulfillment of the orders. For example, dose orders can beprocessed faster if the same medication is required because there isless cross-contamination and medication changes (i.e., retrieval andstorage). Thus, dose orders can be grouped by type or medication, suchthat dose records requiring the same medication or with no risk ofcross-contamination can be processed in order by the same machine, orset of machines. Alternatively, dose order records can be prioritized byurgency. For example, if a doctor urgently needs a specific medication,the data stream identifying the dose can include information indicatingits urgency, and the dose order record can include such urgencyinformation. Thus, an urgent order can be moved near the front of thequeue, or identified as urgent and therefore receive immediate orexpedited fulfillment. Through this or a similar mechanism, the nextunfulfilled dose order retrieved at step 140 can be ordered to optimizethroughput or to satisfy priorities.

Furthermore, as dose orders are received and parsed 110 or processed140, the system can analyze the supplies necessary to fulfill the order.The list of required supplies can be compared to an inventory ofsupplies and their availability, optionally broken down by hospital,pharmacy location, or workstation. If there are insufficient supplies,additional supplies can be automatically ordered or the relocation ofsupplies from one workstation to another can be ordered such that atleast one workstation will have the necessary supplies to fulfill thedose order.

Each dose order record initially has an unprocessed status and isoperated upon by a particular workstation that is selected to convertthe dose order into a particular drag dosage form in fulfillment of theorder. A workstation can be adapted for a particular purpose, such as toinclude automated pill counters, automated syringe preparation,automated intravenous compounding stations, or be configured for manualpreparation. By examining the dose order record, the fulfillment systemcan determine the appropriate workstation among available resources towhich to assign the dose order at step 142, in view of the dosage orderitself or its urgency, that is, its priority requirement for completion.The workstation assignment can further consider the supplies required tofulfill the dose order and the supplies available at each workstation.Also, at step 141, by examining the dose order record, the fulfillmentsystem can determine whether a prepared dosage form is being stored,based on the contents of an inventory record, which can be matched tothe dose order so as to fulfill that order, as indicated at step 144. Inthe event that a match is located, the further steps of FIG. 1A do notneed to be performed in order to provide the source of the order withthe requested dosage form; however, to prevent inventory depletion, theorder can be processed at a priority (that is, in a time frame) that isless urgent than indicated in the order itself since the preparation ofa drug dosage form based on the dose order is for the purpose ofrestocking the inventory. Also, in the event of a match, a person can bedirected to a particular location associated with the drug dosage formso as to retrieve it from inventory, and the retrieval can be registeredso that the inventory record can be updated to reflect that event.

It would be understood by one of skill in the art, that workstations canbe located either centrally or in a distributed environment. Dose orderscan be retrieved or sent to workstations via standard data messagingtechniques. A centralized environment allows for the pooling ofresources. However a distributed environment allows fulfillment to becompleted closer to the end user and can reduce some of theinefficiencies of centralization.

At step 150 each dose order record can be examined to determine if it isappropriate for an automated workstation, or an operation type of aselected workstation can be determined, for example, based on a flag orother setting associated with the workstation such as availability andsetup. If the dose order record is not appropriate for automatedfulfillment, the order can be queued at a manual workstation andprocessed at step 170. However, before the dose order record isdispatched to a manual work station, additional information tofacilitate the manual fulfillment of the dose is preferably provided tothe selected workstation. This can be based on the determination thatmanual preparation is required and the assumption that providingadditional information can improve safety, efficiency, and precisionduring fulfillment of the dose order. The additional information can beassociated with the dose order record. For example, at step 160 themedication and form of dose (e.g., syringe, IV, etc.) specified by thedose order record can be examined so as to determine the protocol bywhich the dose of that medication should be prepared. The protocol canspecify the steps (e.g., sanitization and documentation) that must betaken during preparation to comply with Food and Drug Administrationregulations or any other governing procedures regarding the conduct ofthe pharmacy. Furthermore, the protocol associated with the dose orderat steps 160 and 162, can guide the technician through the fulfillmentprocess to achieve the same level of accuracy and dose safety which istypically associated with the automation. For example, the protocol canrequire the technician's input and process logging at critical stages ofthe dose preparation process (e.g., requiring the technician to scaninformation related to the source drug containers).

The additional information (i.e., protocol) can be associated with thedose order record at step 162. The association can be accomplished byattaching the protocol file to the dose order record, or otherwisecommunicating it electronically to the workstation selected for handlingthat dose order, or by printing a copy of the protocol to include with aprinted order for the dose. In a paperless environment, the protocol ispreferably displayed along with the display of the order or can appearas a hyperlink or call-up dialog box from within the order display.

The workstation can include various tools and monitoring equipment toassist and perform quality control during the manual preparation of thedose order. Such tools and monitoring equipment can include barcodescanners, digital cameras, scales, hydrometers, spectrometers, and othertools that can be used to verify the properties of a substance. Forexample, a computer monitor at the workstation can prompt the operatorto take certain measurements of the dose order being prepared and inputthe results of those measurements. Failure to input a measurement withinan acceptable range can result in the system automatically rejecting thepreparation. Furthermore, to prevent operator fraud, the system canprompt the operator to place the preparation on a scale, or withinanother instrument, that automates the measurement, thereby reducing theopportunity for the operator to deceive the system.

Quality control can include the recordation and logging of anytechnician or operator involved in the preparation of a dose order. Theidentity of the technician or operator can be recorded by fingerprint,key-card, username, password, or other known methods of identification.Additionally, quality control tasks can be assigned to specificworkstations or operators, such as supervisors or quality controlspecialists.

If it is determined at step 150 that the dose order record is suitablefor automated handling, it will be queued at an appropriate automatedworkstation. Queuing the dose order record at a workstation presents afurther opportunity to optimize the distribution of orders within thepharmacy. For example, it may not be feasible to determine at step 140an optimal organization of dose order records to ensure that dose orderrecords requiring similar medications are queued at the sameworkstation. Thus, at step 170, a particular dose order can be queued ata work station that is known to be processing the same medication, or ata workstation at which a dose order involving the same medication wasjust queued. Re-ordering and queuing of dose orders can be very flexibleif the urgency of the dose order is very low. For example, the doseorders can be queued in a less than optimal order with respect to time,but more efficient with respect to medication changes and cleanings toprevent cross-contamination. Optionally, the current workload and/orwork distribution of dose orders to workstations can be tracked ormonitored and presented to a user (e.g., presented on a centralizeddisplay) for management and performance monitoring.

Moreover, various quality assurance activities can be assigned toworkstations. These activities can include mandatory cleaning, trainingsessions, or inventory procedures. They can be scheduled at aworkstation based on necessity (e.g., if the workstation is determinedto be “dirty”), passage of time (e.g., protocol can call for cleaning ortraining every two hours or two days), or by need (e.g., monitoringprocedures determine that certain equipment is “dirty” or that aparticular operator is making mistakes and requires additionaltraining). As used herein, “dirty” refers to a station being in a queuefor a cleaning.

Once the workstation fulfills the dose order, the status of the doseorder record can be changed to indicate that it has been processed atstep 180. The status change can be received by the fulfillment system asan acknowledgement that the drug dosage form has been prepared, or as a“processed-order” status, and this can further result in an update tothe dose order record, the inventory record, or both of drug dosageforms prepared but not yet delivered. Additionally, data concerning theassignment of the dose order to the selected workstation and thecompletion of the dose order can be logged in the database. Logginginformation concerning which workstation processed the dose order, asindicated at step 190, enables the complete tracking of the order andprepared dose from its entry as data to the pharmacy to its delivery tothe patient.

The foregoing discussion details the process by which a data streamcontaining medication dose order information enters the pharmacy and isfulfilled to produce the associated dose. The fulfillment system isfurther capable of responding to any status inquiries concerning a givendose order with order status (e.g., “unprocessed,” “in-progress at{selected workstation},” “processed” and the like) and optionally alocation (e.g., in bin A, on cart B, in pediatric ward, etc.). Thefulfillment system is also capable of monitoring and tracking theprepared dose through to its delivery with additional status information(e.g., dispensation to the patient), as discussed next with reference toFIG. 2.

The workstation identifies the dose as completed at step 200, and thedatabase is updated with completion information at step 202, providing astatus change that can be referenced by persons outside of the pharmacyin response to a status inquiry, and by the system in managing thedistribution of subsequent dose orders. The identification preferablyassociates a unique identifier with the dose. The database recordassociated with the identified dose can be marked as completed.Alternatively, various other subsystems can be notified of thecompletion of the dose. For example, a storage subsystem that tracksmedication that is “on-hand” can be updated with the prepared dose'srecord. Additionally, a delivery subsystem can be notified that theprepared dose is completed and ready for delivery to its destination.

It can be beneficial, for example, to test randomly selected or specificprepared doses for correct preparation. At step 210 a determination ismade as to whether the prepared dose should be tested for correctness.Some prepared doses (e.g., manually prepared doses) requireverification. Procedurally, it can also be beneficial—or evenrequired—to select a prepared dose and verify its proper preparation.Verification can be performed on a random sample or for each prepareddose.

If it is determined at step 210 that the prepared dose should be tested,the database record associated with that dose (e.g., as may beidentified using the doses' unique identifier) is retrieved at step 220.The record can be retrieved by scanning a barcode or other machinereadable indicia included on the dose's container. The barcodepreferably codes the unique identifier associated with dose, and thedatabase record associated therewith is accessed. Alternatively, otherinformation sufficient to uniquely identify the dose can be entered,manually or by machine. Optionally, if a particular sample is identifiedas a test candidate, a duplicate dose order can be introduced into thedosage queue, or it can be re-queued as though never prepared, so that areplacement is prepared.

Preferably, barcode scanners, reconstitution stations, label printersand other devices can be connected to the network to facilitate trackingand processing of dose orders. If, for example, a barcode scanner isconnected to the network via a wireless communication link (e.g., anIEEE 802.11 variant) or as a peripheral to a network connected computer,database records can be updated in real-time as doses are scanned.Alternatively, an offline barcode reader can cache the scannedinformation along with a timestamp of the scan to upload and synchronizedata once it is connected to the network, for example via a dock.

The dose record is displayed at step 222 so that the pharmacist, orother qualified clinician, can compare the database record against thephysical prepared dose. If, at step 230, the pharmacist does not approvethe dose, for example because the quantity does not match the quantityindicated by the database record, the disapproval is preferablyconfirmed at step 240. The pharmacist can further confirm that the doseis to be reassigned for preparation by a workstation, and, at step 242,the dose order record associated with the prepared dose is re-queued inthe database, so that the fulfillment system will process it at step140.

In addition to re-queuing an order record for any reason, thefulfillment system can update the status of the order to “incomplete” or“unprocessed.” Alternatively, it may be desirable to track the number ofprepared orders that are disapproved and the data associated with thoseorders (e.g., the workstation assigned, the pharmacist assigned, themedications and other lab equipment used during preparation, etc.) Insuch a scenario, the database record can be marked as disapproved orrejected and stored for auditing at some future date. If the databaserecord is marked as rejected and stored, a duplicate dose order that ismarked as unfulfilled can be generated and re-queued in the fulfillmentsystem for processing. Preferably, the duplicate dose order indicatesthat it is a re-order of a previously processed order, contains a linkor way to identify the original database record, and includes theoriginal parsed data including an association with the original datastream.

If the pharmacist approves the prepared dose after testing it at step230, the database record is preferably updated to reflect that it wasapproved, as indicated at step 232. If the prepared dose was not testedor was tested and approved, that dose is associated with a location atstep 250. Preferably, the association of the prepared dose and thelocation is accomplished by scanning the barcode included on theprepared dose and a barcode associated with the location where the doseis being stored, with that location being recorded in the database asindicated at step 252. By associating the dose with a location soonafter the dose is prepared, the dose can be fully tracked by itslocation as it moves through the hospital or facility until it reachesits final destination, in the event that a status inquiry is received orthe system polls for that information in connection with the processingor management of other tasks, such as by assigning additional orders tothe workstation at which that dose was just completed.

The location to which the dose is scanned can be a distribution locationor a storage location. Distribution locations can include bins, racks,carts, trays, or any storage mechanism that is used to transport dosesto patients or remote locations. A storage location can include arefrigerator or cabinet in which commonly used medication doses that areprepared in anticipation of use are stored for quick access anddistribution. At step 260, the fulfillment system determines whether thedose was associated with a storage location or a distribution location.

If the dose is staged for storage, the dose order record is updated atstep 262 to reflect its status as “stored” and its storage location.Preferably the database maintains the stored doses and the associateddose record to track the inventory available without requiring dosepreparation. Additionally, the dose record can include an expirationdate, whereby if an urgent order that is received for a particularmedication, the database can be searched for stored doses that have notexpired. Thus, the dose can be delivered to the patient or doctorquickly by retrieving the stored dose and bypassing the preparation andfilling stage. When the stored dose is retrieved for distribution (e.g.,to fulfill a particular order) and removed from storage, its location isscanned again and marked in the database, by again performing stepsanalogous or the same as steps 250 and 252, for tracking of the dosethrough its delivery.

On the other hand, if the dose is staged for distribution, the doseorder record is preferably updated to “ready.” The “ready” statusindicates to a delivery person or other staff person that the medicationis ready to be delivered and administered to the patient. Thus, if anurse or doctor checks on the status of a particular dose order, theuser will be notified that the dose is ready and delivery can beexpedited if necessary. Likewise, the system can access and use thatstatus information in connection with the processing or management ofother tasks.

When a staff member retrieves the bin in which the dose is stored, andthus begins the dose's journey to its final destination, the bin isscanned at step 272 and the status of the dose, and any other dosesknown to the system as being held in the bin, is updated to “indelivery” at step 274. The bin can be used to update the location of alldoses contained therein. Thus, if the bin is moved to a centralizeddistribution center on another floor, when the bin arrives at thedistribution center, the bin can be scanned again and its locationupdated to indicate the distribution center. Therefore, the last knownlocation of every dose can be tracked.

Preferably, the last known person to control the location of the dose isalso recorded. Tracking the person can be performed by assigningindividuals their own scanner on a temporary or permanent basis orrequiring a user to input a personal identifier whenever an item isscanned.

The bin, and all doses stored within the bin, travel through thefacility and are preferably scanned at each location, until it reachesits final destination, and is scanned at step 280. Scanning can beperformed manually or automatically. For example, if the item beingtracked is bar-coded or includes a computer readable identifier,scanners, which can be located throughout the facility, can be used toscan the item as it travels. After being scanned, the location of theitem associated with the bar-code can be automatically updated in thedatabase. Alternatively, passive or active RFID tags can be used totrack the items by locating throughout the facility automated sensorswhich can detect each item when it comes within range of one of thesensors. Upon detecting the item, the item's identification can be read(e.g., passively or actively) from the tag and its associated locationupdated in the database.

When the individual dose is removed from the bin so that it can beadministered to the patient, it is scanned at step 282 and its status isupdate to “delivered.” In a further aspect of tracking and accountingfor medication doses, the dose can be scanned once it has beenadministered, or once administration has begun (e.g., in the case of anintra-venous drip in which administration occurs over a period of time.)Additionally, the patient to whom the dose is administered can berecorded to ensure the correct patient received the prescribedmediation. Preferably, the patient's record includes a barcode or otherindicia that can be scanned and associated with the administration ofthe dose.

Information concerning the dose can also be gathered from virtualcheckpoints during transport and even after being administered. Forexample, the dose can be scanned and associated with a particularinfusion pump. Thereafter, data from the infusion pump can betransmitted to the system and associated with the dose.

Thus, the fulfillment system described above tracks a medication orderfrom its point of origin to its point of consumption. The data collectedas it progresses through the system enables very thorough auditing andmonitoring of the system. Furthermore, the pharmacy can be operated moreefficiently by managing multiple orders and multiple workstations so asto optimize order priority and physical preparation.

While the invention has been described in connection with a certainembodiment thereof, the invention is not limited to the describedembodiments but rather is more broadly defined by the recitations in theclaims below and equivalents thereof.

1. A method for centrally managing dose order preparation, comprisingthe steps of: retrieving at a monitoring computer a dose order recordhaving an unprocessed status; selecting a workstation from among a setof workstations, at least one being an automated workstation, to handlethe unprocessed dose order; forwarding the unprocessed dose order to theautomated workstation for conversion into a drug dosage form; andrepeating the steps of retrieving, selecting, and forwarding.
 2. Themethod of claim 1, further comprising the steps of: determining anoperation type of the selected workstation; and selectively providing aprotocol concerning preparation of the unprocessed dose order to theselected workstation based on the operation type of the selectedworkstation.
 3. The method of claim 2, wherein the selected workstationhas a manual operation type and wherein the protocol is provided inresponse to the operation type being the manual operation type.
 4. Themethod of claim 3, further comprising the steps of: prompting anoperator of the selected workstation to provide information inputregarding the protocol; receiving the information input; analyzing theinformation input to verify preparation in conformance with theprotocol.
 5. The method of claim 2, wherein the selected workstation hasan automated operation type and wherein the test resulting inselectively providing the protocol fails in view of the operation typebeing the automated operation type.
 6. The method of claim 1, includingthe additional steps of: receiving at the monitoring computer from theselected workstation a processed-order status indication; and updatingthe dose order record to the processed-order status.
 7. The method ofclaim 6, including the additional step of responding from the monitoringcomputer to any status inquiry concerning the dose order with theprocessed order status.
 8. The method of claim 6, wherein the updatingstep includes updating a location of the drug dosage form to be that ofthe selected workstation.
 9. The method of claim 8, including theadditional step of responding from the monitoring computer to any statusinquiry concerning the dose order with the processed order status andthe location.
 10. The method of claim 6, including the additional stepsof: supporting a first interrogatable tag on the drug dosage form; andlinking the first interrogatable tag to the dose order record.
 11. Themethod of claim 10, including the additional step of associating acurrent location of the drug dosage form with a location.
 12. The methodof claim 11, wherein the location has a second interrogatable tag andwherein the associating step comprises interrogating the first andsecond interrogatable tags and storing information associated with eachresponse in the dose order record.
 13. The method of claim 1, whereinthe retrieving step retrieves the unprocessed dose order record fromeither a memory or a file or a database.
 14. The method of claim 1,wherein the selecting step updates the dose order record to associatethe dose order with the selected workstation.
 15. The method of claim 1,wherein the retrieving step receives a plurality of dose order records,and wherein the method includes the additional step of arranging theplural dose order records in accordance with a rule.
 16. The method ofclaim 15, wherein the arranging step comprises grouping the plural doseorder records by either type or medication, wherein the dose orderrecords in the group are all forwarded to the selected workstation. 17.The method of claim 15, including the additional step of identifying anurgency associated with one of the plural dose order records, whereinthe identified dose order is forwarded to the selected workstation forconversion into a drug dosage form with a higher priority for handlingthan any unprocessed dose order that has been forwarded to the selectedworkstation.
 18. The method of claim 15, further comprising the stepsof: generating a supply-list identifying a plurality of suppliesrequired to fulfill the plurality of orders; comparing the supply-listwith an inventory of supplies; and ordering one or more of the pluralityof supplies not in the supply-list.
 19. (canceled)
 20. (canceled) 21.(canceled)
 22. (canceled)
 23. (canceled)
 24. A method for centrallymanaging logistics of a dose order fulfillment, comprising the steps of:receiving the dose order at a first station, the dose order having afirst priority for completion; comparing the dose order against aninventory record of prepared drug doses for a match; in the event of thematch: directing a person to a location associated with the matched,prepared drug dose; registering the retrieval of the prepared drug dosefrom the location for delivery to another location; updating theinventory record; and instructing the preparation of the dose order at asecond station for completion at a priority which is not greater thanthe first priority.
 25. (canceled)
 26. (canceled)
 27. (canceled) 28.(canceled)
 29. A method for centrally managing dose order preparation,comprising the steps of: receiving at a monitoring computer a medicationorder containing one or more dose order records; assigning anunprocessed status to each dose order record among the received doseorder records; retrieving a dose order record having an unprocessedstatus; selecting a workstation from among a set of workstations tohandle the unprocessed dose order; forwarding the unprocessed dose orderto the selected workstation for conversion into a drug dosage form; andproviding to the workstation a standard order process protocol suitablefor confirming any dose preparation steps.
 30. (canceled)
 31. (canceled)